Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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A healthcare facility reported their end-to-end targeting accuracy was out of specification. the position of one of the robotic manipulator axes differed from the position determined by the robotic controller. error 103 (karel e-stop detected) and error 342 (deviation in absolute position value dse - rdc) were displayed.